5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
c4c-S - conect4children Stichting |
|
| Evidence of collaboration with regulatory authorities | Yes | When providing expert advice regulatory requirements are being taken into account. For trial services support in gaining the necessary approvals was provided within the network. |
| Capacity to provide competent consultation to regulatory authorities | Yes | The network can provide insights on general non compound related questions of regulatory authorities e.g in the past provided information to PDCO. Due to conflict of interest policies experts cannot participate in EMA scientific committees. |
| Formal meetings for clinical trials | Yes | For each of the trials executed within the network site staff as well as c4c-S core staff have regular meetings with the (local) the trial teams as well as participating in investigator meetings etc. |
| Training courses given over the last 2 years | Yes | All trainings developed can be found at: https://conect4children.org/c4cacademy/ Webinars and face to face training were provided to the network experts on topics like: Artificial Intelligence, Paediatrics Formulations, Safety, Regulatory developments, Data standards, etc. |
| Training courses received over the last 2 years | Yes | All training developed have been available to all the network members. |
| Promotion of participation in clinical trials in countries with limited resources | No | c4c is engaged with partner networks that deliver trials in these settings regarding certain network relevant topics (eg site standards) |
| List of Countries |